OEL Fastrac Catalog

Isoniazid (INH) is a synthetic derivative of nicotinic acid with antimycobacterial properties. It is indicated for the treatment of all forms of tuberculosis in organisms which are susceptible. Isoniazid is a prodrug and must be activated by bacterial catalase. Specifically, activation is associated with reduction of the mycobacterial ferric KatG catalase-peroxidase by hydrazine and reaction with oxygen to form an oxyferrous enzyme complex. Once activated, isoniazid inhibits the synthesis of mycolic acids, an essential component of the bacterial cell wall. At therapeutic levels, isoniazid is bactericidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms. Specifically, isoniazid inhibits the 2- trans-enoyl-acyl carrier protein reductase (InhA), the enoyl reductase from Mycobacterium tuberculosis, by forming a covalent adduct with the nicotinamide adenine dinucleotide (NAD) cofactor. It is the INH-NAD adduct that acts as a slow, tight-binding competitive inhibitor of InhA.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Isoniazid, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.